Copy to clipboard 
This collection of five companies operates in the spine, trauma and robotic/digital segments. For lesser-known emerging entities, a brief bio is included. These new solutions aim to enhance pelvic fracture fixes and simplify cervical and lumbar spine surgeries.
Spine
ArtFx Medical | Venus Cervical Plate, K211718
Submitted June 2021, granted June 2022
Primary predicate: Stryker Spine NuLock Anterior Cervical Plating System, K083562
About the product: Titanium alloy-based implant, providing high strength with low thickness; features a simple locking mechanism, high degree of titanium alloy screw angulation and streamlined instrumentation, plus five different length options with two different diameters.
About the company: Founded in 2010, based in Jacksonville, Florida; portfolio includes spinal and trauma implants, as well as surgical instruments.
ulrich medical USA | Flux-C 3D Porous Titanium Cervical Interbody System, K220696
Submitted March 2022, granted August 2022
Primary predicate: K2M Cascadia Cervical 3D Interbody System, K160125
About the product: 3D-printed porous titanium device manufactured with direct metal laser sintering. The interbodies are available in multiple parallel and lordotic options and in various heights. These porous titanium devices are designed with a large graft window and a side window to allow for improved radiographic imaging.
Robotics/Digital
Accelus (filing as Fusion Robotics)| Remi Robotic Navigation System software update, K223070
Submitted September 2022, granted October 2022
Primary predicate: Practical Navigation Surgical Guidance System, K202184
About the product: An image-guided system  comprising a computer workstation, trajectory system that includes a targeting platform,  camera and various image-guided instruments intended for assisting the surgeon in placing screws in the pedicles of the lumbar spine. The software update allows image capture with the GE OEC 3D, Ziehm Vision RFD 3D and Stryker Airo TruCT systems. All Remi Robotic Navigation Systems in the field will be updated to the newly cleared software and will  continue to be compatible for use with O-arm imaging.
DePuy Synthes | TELIGEN Digital Tools, K213978
Submitted December 2021, granted October 2022
Primary predicate: Viseon Voyant System, K191579
About the product: Indicated to provide minimally invasive access, visualization, illumination, magnification and discectomy of the spine during transforaminal lumbar interbody fusion. Comprises a tower that delivers a suite of technologies, including camera control, a VueLIF-T Procedure Kit with disposable HD camera, a TELIGEN Clear Discectomy Device and patient-based disposable ports. TELIGEN integrates with the UNLEASH bundle of implants. The digitally enabled TELIGEN VUE Camera is designed to eliminate the need for a microscope and  provides an unobstructed view of the surgical site. It offers hands-free visualization during  procedures, along with a multidirectional and expanded field of view. The self-cleaning camera includes LED lighting and allows surgeons to manipulate image clarity based on their preferences. A heads-up display allows surgeons to maintain ergonomic postures during procedures.
Trauma
CurvaFix | Smaller-diameter CurvaFix Intramedullary Implant, K222505
Submitted August 2022, granted October 2022
Primary predicate: CurvaFix Intramedullary Rodscrew System, K180050
About the product: The latest addition to a collection of flexible intramedullary devices for pelvic fracture fixation. This new 7.5mm device is designed to provide strong, stable, curved fixation in smaller patients. Clinical case reports  indicate  the CurvaFix IM Implant achieves strong, stable fixation that follows and fills the natural curvature of each patient’s anatomy. These features  can immediately reduce pain, allow for earlier mobility and improve patient recovery. The implant addresses many pelvic fracture fixation challenges and enables surgeons to fix fragility fractures of the pelvis in geriatric patients.
About the company: Founded in 2013, headquartered in Bellevue, Washington. Leadership brings experience from roles at ArthroCare, Ellipse Technologies, NuVasive Specialized Orthopedics and Tornier. To date, CurvaFix has raised  $13.2 million in funding over four rounds.
